Overview

Investors

Bonus Biogroup (TASE:BONS) is a clinical-stage biotechnology company developing 'next-generation’, innovative, cost-effective cell therapy solutions for various indications in regenerative medicine with prevalent and unmet clinical needs. Leveraging our proprietary technology platform, we are advancing two lead product candidates - BonoFill and MesenCure - which are currently being evaluated in clinical trials for their potential applications in tissue engineering and cell therapy.

View Company Presentation

Click here

BonoFill

A personalized, tissue-engineered, viable bone graft derived from the patient's cells for bone tissue regeneration. BonoFill is designed to address the limitations of existing bone regeneration and reconstruction therapies. This autologous cell-based product candidate combines cells on a three-dimensional (3D) biocompatible and bioactive mineral scaffold cultivated using our proprietary bioreactor growth system. The result is a live bone graft grown ex vivo (outside the human body), which is intended to be tailored to each patient's unique biological, physical, and clinical needs. The manufacturing process of BonoFill takes approximately two weeks to complete after receiving the patient cell sample. By leveraging the natural compatibility of autologous cells with the patient's body, BonoFill aims to optimize treatment outcomes, minimize immune reactions, and eliminate the risk of graft failure.

Currently under clinical evaluation for maxillofacial, dental, and orthopedic applications.

A Phase II trial for maxillofacial bone defects has been completed, showing a 90% success rate, with a Phase III study planned, pending FDA clearance.

An additional Phase II trial for orthopedic indications is ongoing. Enrollment completion is expected in 2025, with interim results expected in 2026.

MesenCure

An enhanced investigational allogeneic cell therapy designed for treating inflammation and tissue damage is initially indicated for treating respiratory distress, including ARDS, a life-threatening condition caused by the lungs' inability to adequately oxygenate the body. The active pharmaceutical ingredient in MesenCure is an innovative composition of allogeneic cells derived from healthy donor adipose tissue MSCs through a proprietary process designed to enhance the MSCs' therapeutic potential. Currently administered in up to three doses, these cells are designed to target the lungs, presumably leveraging multiple pleiotropic mechanisms to counteract inflammation and foster lung tissue regeneration, with the potential to address the multifaceted pathology of acute lung injury (ALI) and subsequent respiratory distress.

Evaluated in a completed Phase II clinical trial for its ability to modulate inflammation and support lung recovery in severely ill patients with pneumonia and respiratory distress due to COVID-19.

In 2025, the FDA cleared an Investigational New Drug (IND) application for a Phase III trial targeting COVID-19-related pneumonia.

The Company is working on amending the clinical protocol to broaden the scope of the Phase III trial to include patients with respiratory distress from all causes, including ARDS, pending FDA clearance.

FOR MORE INVESTOR RELATION INFORMATION

Press Release, Announcements publication and more